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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K211655
Device Name aPROMISE
Applicant
EXINI Diagnostics AB
Ideon Science Park, Scheelevägen 27
lund,  SE se-223 70
Applicant Contact aseem anand
Correspondent
Biologics Consulting Group
1555 King Street
alexandria,  VA  22314
Correspondent Contact donna-bea tillman
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/28/2021
Decision Date 07/27/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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